MAUDE Adverse Event Report: MEDTRONIC VASCULAR ADMIRAL; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Lot Number 211507180

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 08/15/2017

Event Type  malfunction  

Event Description

Patient scheduled for an abdominal runoff in the cardiac cath lab.Procedure started, during procedure patient went into pea.Code started, rt, anesthesia at bedside with cath lab staff and primary md.Patient received acls medications and blood transfusion without improvement.Admiral balloon 8/40 lot #211507180.

• Brand Name: ADMIRAL
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC VASCULAR; 3850 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7005705
• MDR Text Key: 91293227
• Report Number: 7005705
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Lot Number: 211507180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR